Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

This study is looking at whether people with early relapsing multiple sclerosis (RMS) can stop taking ocrelizumab (a medication for MS) after a period of treatment. All participants will first receive ocrelizumab for 24 months. Then, some will continue with ocrelizumab, while others will switch to a placebo (an inactive substance). Researchers want to see if stopping ocrelizumab leads to a return of MS symptoms, specifically clinical relapses, over a 2-year period. You might be eligible if you are 18-55 years old and have been recently diagnosed with early RMS. The study is currently recruiting about 123 participants, but its exact status is unclear.

Study design: This is a multi-center, randomized, double-blinded, placebo-controlled study involving about 123 participants. Participants will first receive ocrelizumab, then be randomly assigned to continue ocrelizumab or switch to a placebo.
What's involved: Participants will receive ocrelizumab infusions for 24 months, followed by either ocrelizumab or placebo infusions for another 24 months, for a total of 48 months. This includes regular assessments like physical and neurological exams, MRI scans, and blood and stool sample collection.
Compensation: Not stated in the trial record.
Follow-up: The primary goal is to measure the absence of clinical relapse from Month 24 to Month 48, which is the end of the treatment period.

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Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis

Recruiting

PHASE4Ages 18–55InterventionalTreatment

National Institute of Allergy and Infectious Diseases (NIAID)

~123 participants

Updated 2026-08-10 on ClinicalTrials.gov

What's tested:OcrelizumabPlacebo for Ocrelizumab

At a glance

Recruiting sites

13 of 13 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Absence of clinical relapse

Measured over From Month 24 to Month 48

Conditions

Multiple Sclerosis

Where it's being run

13 sites across 10 states

Massachusetts2

New York2

Texas2

Connecticut1

District of Columbia1

Illinois1

New Jersey1

Oklahoma1

Study leadership

Amit Bar-Or, M.D. · STUDY_CHAIR · University of Pennsylvania, Perelman School of Medicine: Department of Neurology

Who to contact

Amit Bar-Or

(215) 316-5151

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage

CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, CNS sarcoidosis, or systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments 5. Pregnancy or lactation

Psychosis not controlled by a treatment

Hypersensitivity to any of the constituents or excipients of the preceding steroids 18. Current or prior treatment with the following MS DMTs: fingolimod and other S1P receptor modulators, cladribine, natalizumab, anti-CD20 molecules, alemtuzumab, and chemotherapeutic agents 19. Treatment with fumarates within 30 days prior to collection of Mo 0/Day 0 mechanistic samples, Mo 0/Day 0 MRI, and Mo 0/Day 0 infusion 20. (a) Current or prior treatment with any approved or experimental immunomodulatory therapies, unless reviewed and approved by the SAC (Section 3.6), or (b) Treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency) 21. Systemic corticosteroid therapy within 4 weeks prior to the collection of screening mechanistic samples and the screening MRI 22. Systemic corticosteroid therapy within 4 weeks prior to the Mo 0/Day 0 infusion 23. Screening laboratory test results as follows:

Positive infection screening tests for:

A reactive RPR test unless followed by a subsequent negative RPR OR

A reactive RPR test unless successful completion of treatment has been documented as well as a consultation with and clearance by infectious disease department iv. HIV v. At or within twelve months of screening:

Positive QuantiFERON®-TB Gold test or positive purified protein derivative tuberculin skin test (PPD) (\>5mm induration, regardless of Bacille Calmette-Guerin (BCG) vaccine administration) unless completion of treatment has been documented for active TB OR

An indeterminate QuantiFERON®-TB Gold test unless followed by a subsequent negative PPD or negative QuantiFERON®-TB Gold test as well as a consultation with and clearance by infectious disease department

Levels of serum immunoglobulin G (IgG) \< 3.3g/L

Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x the upper limit of normal (ULN)

Platelet count \< 100,000 plt/µL (\<100 x 10⁹/L)

Hemoglobin \< 10 g/dL

Absolute neutrophil count \< 1.5 x 10⁹/L

Absolute lymphocyte count \< 1.2 x 10⁹/L 24. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.

What this trial measures

Absence of clinical relapseFrom Month 24 to Month 48
Durable remission of relapsing disease activity. This is defined as the absence of new relapsing disease activity from Month 24 through Month 48. This includes absence of clinical relapse as well as absence of evidence of MS disease activity by MRI defined by new or enlarging T2 lesions.

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